Evidence map›Paper›PMID 38439092›Full record

ArticleBMC psychology2024

Clinical effectiveness, cost-effectiveness and process evaluation of group schema therapy for eating disorders: study protocol for a multicenter randomized controlled trial.

Suzanne H W Mares, Jeffrey Roelofs, Janôt Zinzen, Manouk Béatse, Hermien J Elgersma, Ruben M W A Drost, Silvia M A A Evers, Annemarie A van Elburg

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC psychology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05812950 (Clinical and Cost-effectiveness of Group Schema Therapy for Complex Eating Disorders), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
3.2field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05812950 narecruitingnot on this map

Clinical and Cost-effectiveness of Group Schema Therapy for Complex Eating Disorders: the GST-EAT Study

TypeinterventionalSponsorMaastricht UniversityRan2023 to 2026Enrolled230ConditionsAnorexia Nervosa, Atypical Anorexia Nervosa (Other Specified Eating Disorder), Bulimia Nervosa, Atypical Bulimia Nervosa (Other Specified Eating Disorder)ArmsGST, CBT-E
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 1 country.

Suzanne H W Mares *Department of Eating Disorders (Amarum), GGNet Mental Health, St. Annastraat 312c, Nijmegen, 6525 HG, The Netherlands. s.mares@ggnet.nl.
Jeffrey Roelofs *Clinical Psychological Science, Faculty of Psychology and Neuroscience, Experimental Psychopathology, Maastricht University, Maastricht, 6200 MD, The Netherlands.
Janôt ZinzenClinical Psychological Science, Faculty of Psychology and Neuroscience, Experimental Psychopathology, Maastricht University, Maastricht, 6200 MD, The Netherlands.
Manouk BéatseDepartment of Eating Disorders (Amarum), GGNet Mental Health, St. Annastraat 312c, Nijmegen, 6525 HG, The Netherlands.
Hermien J ElgersmaDepartment of Clinical Psychology & Experimental Psychopathology, University of Groningen, Groningen, the Netherlands.
Ruben M W A DrostDepartment of Health Services Research, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences (FHML), Maastricht University, Maastricht, the Netherlands.
Silvia M A A EversDepartment of Health Services Research, Care and Public Health Research Institute (CAPHRI), Faculty of Health, Medicine and Life Sciences (FHML), Maastricht University, Maastricht, the Netherlands.
Annemarie A van ElburgDepartment of Eating Disorders (Amarum), GGNet Mental Health, St. Annastraat 312c, Nijmegen, 6525 HG, The Netherlands.
Maastricht University · NLUtrecht University · NLGGNet · NLTrimbos Institute · NLUniversity of Groningen · NL

Funding

ZonMw 60-63600-98-1131
6 · The paper itself

Abstract

backgroundEating disorders (EDs), such as (atypical) Anorexia (AN) and Bulimia Nervosa (BN), are difficult to treat, causing socioeconomic impediments. Although enhanced cognitive behavioral therapy (CBT-E) is widely considered clinically effective, it may not be the most beneficial treatment for (atypical) AN and BN patients who do not show a rapid response after the first 4 weeks (8 sessions) of a CBT-E treatment. Alternatively, group schema therapy (GST) may be a valuable treatment for this ED population. Even though GST for EDs has yielded promising preliminary findings, the current body of evidence requires expansion. On top of that, data on cost-effectiveness is lacking. In light of these gaps, we aim to describe a protocol to examine whether GST is more (1) clinically effective and (2) cost-effective than CBT-E for (atypical) AN and BN patients, who do not show a rapid response after the first 4 weeks of treatment. Additionally, we will conduct (3) process evaluations for both treatments.

methodsUsing a multicenter RCT design, 232 Dutch (atypical) AN and BN patients with a CBT-E referral will be recruited from five treatment centers. Clinical effectiveness and cost-effectiveness will be measured before treatment, directly after treatment, at 6 and at 12 months follow-up. In order to rate process evaluation, patient experiences and the degree to which treatments are implemented according to protocol will be measured. In order to assess the quality of life and the achievement of personalized goals, interviews will be conducted at the end of treatment. Data will be analyzed, using a regression-based approach to mixed modelling, multivariate sensitivity analyses and coding trees for qualitative data. We hypothesize GST to be superior to CBT-E in terms of clinical effectiveness and cost-effectiveness for patients who do not show a rapid response to the first 4 weeks of a CBT-E treatment. DISCUSSION: To our knowledge, this is the first study protocol describing a multicenter RCT to explore the three aforementioned objectives. Related risks in performing the study protocol have been outlined. The expected findings may serve as a guide for healthcare stakeholders to optimize ED care trajectories.

trial registrationclinicaltrials.gov (NCT05812950).

Indexed as

Feeding and Eating DisordersQuality of LifeCost-Benefit AnalysisHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicSchema TherapyTreatment Outcome(Atypical) Anorexia nervosa(Atypical) Bulimia nervosaClinical effectivenessCognitive behavioral therapyCost-effectivenessCost-utilityEating disordersEconomic evaluationGroup schema therapyRandomized controlled trial

Identifiers

PMID38439092
PMCPMC10913254
OpenAlexW4392367093

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.